Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of inhaled isoflurane delivered via the sedaconda acd-s compared to intravenous propofol for sedation of mechanically ventilated intensive care unit adult patients (inspire-icu2)

Conditions: Sedation

Summary: this is a study to compare safety and efficacy of inhaled isoflurane administered via the sedaconda acd-s device system versus intravenous propofol for sedation of mechanically ventilated patients in the intensive care unit (icu) setting.

this is a phase 3, multicenter, randomized, controlled, open-label, assessor-blinded study to evaluate the efficacy and safety of inhaled isoflurane delivered via the sedaconda acd-s compared to intravenous propofol for sedation of mechanically ventilated intensive care unit (icu) adult patients.

Eligibility criteria:
inclusion criteria: * adults ≥18 years of age; * patients who are anticipated to require \>12 hours of invasive mechanical ventilation and continuous sedation in the icu; and * receipt of continuous sedation due to clinical need for sedation to rass \<0. exclusion criteria: * need for rass -5; * sedation for invasive mechanical ventilation immediately prior to baseline for \>72 hours; * severe neurological condition before icu admission that causes the patient to lack ability to participate in the study (ie, unable to be assessed for rass and cpot); * ventilator tidal volume \ 1000 ml at baseline; * need for extracorporeal membrane oxygenation (ecmo), extracorporeal co2 removal (ecco2r), high frequency oscillation ventilation (hfov), or high frequency percussive ventilation (hfpv) at screening; * comfort care only (end of life care); * contraindication to propofol or isoflurane; * known or family history of mh; * severe hemodynamic compromise, defined as the need for norepinephrine ≥0.3 mcg/kg/min (or equivalent vasopressor dose) to maintain blood pressure within acceptable range, assumed to be mean arterial pressure ≥65 mmhg unless prescribed clinically; * allergy to isoflurane or propofol, or have propofol infusion syndrome. * history of ventricular tachycardia/long qt syndrome; * requirement of iv benzodiazepine or barbiturate administration for seizures or dependencies, including alcohol withdrawal * neuromuscular disease that impairs spontaneous ventilation (eg, c5 or higher spinal cord injury, amyotrophic lateral sclerosis, etc); * concurrent enrollment in another study that, in the investigator's opinion, would impact the patient's safety or assessments of this study; * participation in other study involving investigational drug(s) or devices(s) within 30 days prior to randomization; * anticipated requirement of treatment with continuous infusion of a neuromuscular blocking agent for \>4 hours; * female patients who are pregnant or breast-feeding; * imperative need for continuous active humidification through mechanical ventilation circuit; * attending physician's refusal to include the patient; or * inability to obtain informed consent.

Keywords: sedation mechanical ventilation propofol icu isoflurane
weight loss in adults over 50 with obesity

Conditions: Obesity

Summary: the purpose of this study is to examine the separate and combined effects of a high-protein (hp) diet and resistance training (rt) on body composition and potential biological moderators of body weight in women and men \>50y. all participants will receive dietary physical activity guidance through our group-based weight loss program, state of slim (sos). the sos program will be delivered via the zoom videoconferencing platform. these participants will be randomized to receive either a counseling-based hp diet plan or rt plan. body composition assessments at 8 wk will identify responders and non-responders; the latter will be re-randomized to "augment" (hp: add protein supplements; rt: supervise rt) or "combine" (hp with protein supplements + supervised rt).


Eligibility criteria:
inclusion criteria: * male or female * age ≥50 years * post-menopausal if female * bmi of 30-50 kg/m2 for ambulatory participants (less than or equal to 350 lbs.) * bmi of 25-50 kg/m2 for wheelchair users (less than or equal to 350 lbs.) * ambulatory with or without a walking device or use of a manual wheelchair for mobility. exclusion criteria: * untreated hyper or hypothyroidism. * cancer (except basal cell). * gastrointestinal disorders affecting food intake. * \<3 months of stable use of medications that affect metabolism, body weight, energy expenditure or appetite. * current eating disorder (e.g., binge eating disorder, anorexia, or bulimia). * any medical condition for which following a hp diet and/or 70 minutes of exercise daily would be inadvisable. * uses a powered wheelchair for mobility. * has a pacemaker or any other life-sustaining medical implant.

Keywords: weight loss dietary protein exercise training fat free mass
the impact of iv acetaminophen on pain after appendectomy for perforated appendicitis

Conditions: Perforated Appendicitis

Summary: the objective of this study is to evaluate two standard post-operative pain regimens routinely used after laparoscopic appendectomy for perforated appendicitis. the investigators hypothesize that the use of intravenous (iv) acetaminophen in addition to iv ketorolac with narcotic pain pump will decrease time to transition off patient/nurse controlled analgesia (pca) to oral pain medications.

to assess pain control, patient and family perception of pain control, time to return of bowel function defined as passage of first flatus (in days), doses of anti-emetic medications, doses of narcotic pain medications, time to toleration of regular diet (in days), narcotic associated adverse effects (nausea, emesis, respiratory depression, constipation), length of stay, and overall hospital cost in admission. post-hospitalization the investigators will assess complications including number and reasons for emergency visits and abscess formation, length of post-hospitalization analgesic use, length of post-hospitalization narcotic use, and time to return to school.

Eligibility criteria:
inclusion criteria: * all patients ages 2-17 years old undergoing laparoscopic appendectomy at cmh found to have perforated appendicitis. exclusion criteria: * non-perforated appendicitis * normal appendix at the time of operation or other associated conditions causing abdominal pain * patients with history of chronic pain * known underlying liver disorders * known allergy to pain medication in protocol * non-english speaking

Keywords: appendicitis pain perforation
effectiveness of act for problematic chemsex

Conditions: Hypersexuality; Compulsive Sexual Behavior; Sexualized Drug Use (Chemsex)

Summary: investigation of the efficacy of acceptance and commitment therapy (act) for the psychological treatment of problematic chemsex.

after being informed about the study, all patients giving written informed consent will be assessed to determine eligibility for study entry. patients who meet eligibility requirements will receive psychological intervention consisting in an 8-session individual on line-delivered act-based treatment. the participants will be assessed through self-report instruments before and after treatment and at 3 months follow-up. the clinical trial will include a control group.

Eligibility criteria:
inclusion criteria: * older than 18 years-old * spanish speaking * having used psychoactive substances to facilitate, maintain and/or improve sexual relations in the last year * significant score on the hbi inventory (of 53 or more) * clinically significant discomfort related to sexual practices * degree of interference in his/her life of sexual practices greater than or equal to 5 out of 10 * desire to improve/reduce excessive sexual behaviour exclusion criteria: * receiving psychological or psychopharmacological treatment * intellectual disability * substance dependence (use not associated with sex) * personality disorder or other serious or chronic mental disorder diagnosed

Keywords: sexuality risky sexual behavior
cessation on internet addiction in college students

Conditions: Internet Addiction Disorder

Summary: this study aimed to explore the intervention effect of tai chi exercise on internet addiction in college students and its maintenance effect after cessation, providing a scientific basis for the application of tai chi in internet addiction intervention among college students. fifty-one non-sports-major college students with mild or moderate internet addiction were randomly divided into a tai chi group (n = 23) and a control group (n = 24). the tai chi group underwent 12 weeks of tai chi exercise, while the control group maintained their regular study schedule without additional physical exercise. the chinese internet addiction scale and serum dopamine and β-endorphin levels were assessed at baseline, week 12, and week 16.


Eligibility criteria:
inclusion criteria: * participants aged 18-25; * cias scores of 26-53 (low internet dependence), 54-80 (moderate dependence), or 81-104 (high dependence). only mild and moderate cases were included; * non-sports majors; the study followed the declaration of helsinki, and all participants understood the purpose and signed consent forms. exclusion criteria: * severe iad (cias score \>80); * tai chi practice within 6 months; * regular exercise habits; * history of depression/anxiety or undergoing psychological treatment; * use of medications affecting mental state or neurotransmitter levels.

Keywords: internet addiction disorder tai chi
angiotensin ii antagonist in severe sepsis

Conditions: Severe Sepsis

Summary: the investigators propose a clinical study of irbersartan for the early treatment of severe sepsis patients with elevated predicted risk of death between. this study will evaluate whether early administration of the the angiotensin receptor blocker irbersartan provides significant reduction of 28 days mortality and multi organ failure incidence to patients with severe sepsis.

background: angiotensin ii (ang ii) is a potent vasoconstrictor and diminishes vasodilator responses in arteries. in addition to direct effects on vascular tone, ang ii affects multiple aspects of microvascular function through promotion of leukostasis, induction of capillary permeability and depletion of glutathione. binding of ang ii to its receptors (in particular at1) mediates intracellular free radical generation that contributes to tissue damage by promoting mitochondrial dysfunction. angiotensin receptor blockers (arbs) interrupt renin-angiotensin system (ras) overactivity by blocking a specific receptor that mediates the pathogenic activity of angiotensin ii. objectives: the clinical question objective of this study is if the antiinflammatory effect of arbs is relevant in sepsis management and in particular if arbs are able to improve survival and reduce the incidence of multi organ failure in septic patients. methods: study design: experimental; prospective, randomized, multicenter, phase iii trial. study population: three hundred adults within 12 hrs of recognition of severe sepsis, with acute physiology and chronic health evaluation (apache) ii-predicted risk of mortality between 20% and 80% are eligible. settings: 5 italian intensive care units. oral irbesartan (total dose of 75 mg) or placebo administered every 24 hrs for 15 days. analysis of data performed by a blind operator. expected results: about 25% reduction in 28-day mortality rate and incidence of multi organ failure in the study population.

Eligibility criteria:
inclusion criteria: adults within 12 hrs of recognition of severe sepsis, with acute physiology and chronic health evaluation (apache) ii-predicted risk of mortality between 20% and 80% are eligible. exclusion criteria:patients already treated with ace inhibitors or arbs will be excluded. patients admitted in shock conditions (systolic blood pressure lower than 90 mmhg) will be excluded. patients with severe renal failure (serum creatinine of 2.0 mg/dl or dialysis) will be excluded.

Keywords: irbesartan, angiotensin, sepsis
nep-tune: neuropathic pain - treatment with pregabalin under real-life conditions in denmark

Conditions: Peripheral Neuropathic Pain

Summary: observational study to assess the effectiveness and use of pregabalin (lyrica) in the treatment of patients with peripheral neuropathic pain in real-life daily clinical practice.

general practitioners and specialists participate in the study. when a subject, independently of the study and before consideration for observation in the study has been prescribed pregabalin for treatment of peripheral nep, the subject can (before first dose of pregabalin is taken) be included in the observational program.

Eligibility criteria:
inclusion criteria: * subjects aged 18 years or over. * subjects diagnosed with peripheral neuropathic pain. * subjects that independently of the study and before consideration for observation in the study have been prescribed pregabalin for treatment of peripheral neuropathic pain either. 1. for the first time ('first prescription patients') or 2. that have not used pregabalin within the previous 6 months but are prescribed pregabalin again ('re-treatment patients') * subjects that haven't taken the first dose of the prescribed pregabalin yet. exclusion criteria: * subjects not consenting to participate. * subjects that at study inclusion (baseline) are on treatment with pregabalin for generalized anxiety or epilepsy.

Keywords: real-life non-interventional observational peripheral neuropathic pain lyrica pregabalin
comparing three dimension laparoscopic versus open surgery for perihiliar cholangiocarcinoma

Conditions: Cholangiocarcinoma, Perihilar; Surgery

Summary: cholangiocarcinoma (cca) is the most common biliary tract malignancy and the second most common primary hepatic malignancy. the prognosis of cca is dismal. surgery is the only potentially curative treatment, but the majority of patients present with advanced stage disease, and recurrence after resection is common. it is classified into intrahepatic (icca), perihilar (pcca), and distal (dcca) subtypes. among all, pcca is the most common subtype. this is a prospective, randomized, controlled multicenter trial with two treatment arms, three dimension laparoscopic approach versus open approach. the trial hypothesis is that three dimension laparoscopic surgery has advantages in postoperative recoveries and be equivalent in operation time, oncological results and long-term follow-up compared with open counterpart. the duration of the entire trial is two years including prearrangement, follow-up and analyses.


Eligibility criteria:
inclusion criteria: 1. histologically proven pcca. 2. highly presumed perihlar bile duct malignancy with difficulties to obtain histological evidence. 3. preoperative staging work up performed by upper abdomen enhanced ct scan. 4. the subject understands the nature of this trial and willing to comply. 5. ability to provide written informed consent. 6. patients treated with curative intent in accordance to international guidelines exclusion criteria: 1. distant metastases: peritoneal carcinomatosis, liver metastases, distant lymph node metastases, involvement of other organs. 2. subjects undergoing any part for hepatectomy. 3. patients with high operative risk as defined by the american society of anesthesiologists (asa) score \>4. 4. synchronous malignancy in other organs. 5. palliative surgery

Keywords: cholangiocarcinoma perihilar three dimension laparoscopic
chronic pain dynamic psychophysical tests and genetic screening

Conditions: Pain

Summary: incidence and risk factors for persistent post surgical pain after caesarean section are investigated. demographic, psychophysical testing and genetic screening factors are performed in the perioperative period. phone survey is performed to investigate the incidence of persistent post surgical pain after caesarean section.

persistent post surgical pain after caesarean section may lead to functional limitation and pain during activities of daily living. demographic factors, psychophysical factors (mechanical temporal summation, diffuse noxious inhibitory control, state trait anxiety inventory) and genetic screening are used to predict the association with persistent post surgical pain. phone survey follow up is performed to investigate the incidence of persistent post surgical pain and functional limitations due to pain experienced.

Eligibility criteria:
inclusion criteria: * women undergoing spinal anaesthesia for caesarean section exclusion criteria: * failed spinal anaesthesia, unable to perform psychophysical testing.

Keywords: pain caesarean section
comparison of the effect of a novel starch (glycosade) versus gastrostomy tube-dextrose infusion on overnight euglycaemia control in children with glycogen storage disease type i: open label demonstration trial

Conditions: Glycogen Storage Disorder Type 1; Hypoglycemia; Cornstarch; Glycosade

Summary: the objective of this demonstration project is to compare a novel long-acting starch, glycosade, a hydrothermally processed high amylopectin maize starch, versus gastrostomy tube-dextrose infusion in maintaining euglycaemia overnight in children with gsd-i. glycosade has been reported to increase the duration of euglycaemia. its slow release and longer periods of normal blood sugar achieved would preclude the need for the overnight dextrose infusion and eliminate the need for the surgical insertion of a gastrostomy tube for this purpose. glycosade also reportedly causes fewer gastrointestinal side effects, thus potentially improving compliance to therapy. the investigators intend to evaluate glycosade in our patients and determine its efficacy on glucose control, on the length of normoglycemia achieved and to determine if there are reduced side effects in our patients with gsd-i. this will be accomplished by an open label study of glycosade in gsd-i patients who consent to the protocol.


Eligibility criteria:
inclusion criteria: * diagnosis of gsd type 1 * age \>5 years exclusion criteria: * n/a
assessment of nonalcoholic fatty liver disease in diabetic and prediabetic patients using noninvasive methods.

Conditions: Non Alcoholic Fatty Liver

Summary: assessment of nafld among diabetic, pre-diabetic and non diabetic participants using non invasive methods.and correlation between lab and radiological methods .

non alcoholic fatty liver disease (nafld) is a major public health problem. with 10-30% prevalence worldwide , and is a common cause of chronic liver disease and the third most common cause of liver transplantation . nafld can range from simple steatosis in the absence of inflammation to nonalcoholic steatohepatitis, liver cirrhosis, and hepatocellular carcinoma (hcc) . major risk factors for nafld include obesity, hypertension , hyperlipidemia , hypertriglyceridemia , and type-2-diabetes mellitus (t2dm) . the gold standard in the diagnosis of nafld is liver biopsy; however, it is sometimes associated with some complications that include bleeding, bile leak, infection, and other potential life-threatening issues. the accuracy of the mri, computed tomography, and ultrasound imaging in diagnosis of nafld is low; hence, fibroscan was introduced . this is a non-invasive, simple-to-perform imaging modality with high accuracy to assess liver stiffness and hepatic fat deposition. non-invasive diagnosis is based on clinical and biochemical markers, scoring models, and algorithms of methods which have sufficient sensitivity, specificity, and reproducibility .

Eligibility criteria:
inclusion criteria: * the participants are divided into 3 groups: the diabetic group patients (t2dm) ,the pre-diabetic and the non diabetic one. the diagnosis will be according to the american diabetes association (ada) clinical practice recommendations-2019 exclusion criteria: * patients under the age of 18. * patients with viral hepatitis (hbv - hcv). * subjects with risk of 2nd hepatic steatosis liver disease (excessive alcohol consumption and medications). * history of liver disease such as (α-1 antitrypsin deficiency, autoimmune hepatitis, drug-induced liver injury, 1ry biliary cirrhosis, 1ry sclerosing cholangitis). * body mass index (bmi) \> 35 (to avoid the possibility of fibroscan failure).
efficacy comparison between primary care physicians' independent auscultation and ai-assisted auscultation for congenital heart disease screening in patient-enriched populations: a randomized controlled trial

Conditions: Congenital Heart Disease (CHD); Screening Tool; Artifical Intelligence; Randomised Controlled Trial; Auscultation for Clinical Evaluation

Summary: in recent years, the application of artificial intelligence (ai) in the healthcare domain has witnessed a significant surge, with deep learning emerging as a potent force in the medical field. deep learning algorithms possess the remarkable ability to automatically extract intricate features and patterns, thereby facilitating highly accurate heart sound recognition. drawing on this technological advancement, professor sun kun and his research team from xinhua hospital, in collaboration with numerous centers spanning across china, have been diligently investigating the development and application of ai-assisted heart sound recognition for congenital heart disease (chd) screening. utilizing electronic stethoscopes to meticulously collect heart sounds, and harnessing ai algorithms to analyze extensive datasets comprising heart sounds from both children diagnosed with chd and those who are healthy, the system has been trained to adeptly differentiate between normal and pathological murmurs. the current iteration of the system boasts an impressive accuracy and sensitivity rate of 90%. this study is designed as a randomized controlled trial (rct) to be conducted at shanghai xinhua hospital and qinghai provincial women and children's hospital. the primary objective is to demonstrate the superiority of ai-assisted primary care physicians in identifying chd over primary care physicians working independently. this will be achieved by conducting a comparative analysis of the performance of ai-assisted physicians versus their unassisted counterparts, thereby substantiating the model's practical applicability. through an ongoing process of refinement and widespread application, this pioneering research endeavors to empower a diverse range of medical professionals, including general practitioners, child health physicians, and non-cardiovascular specialists, with the transformative capabilities of ai-assisted electronic auscultation. the ultimate goal is to elevate the standard of pediatric care across the nation.


Eligibility criteria:
inclusion criteria: * age between 0 to 18 years, with no gender restrictions. * children who consent to undergo echocardiography to determine the presence or absence of congenital heart disease. * voluntary participation in this study and signing of an informed consent form. exclusion criteria: * age greater than 18 years. * children who are unable to undergo echocardiography or who do not cooperate with auscultation. * participants who cannot provide informed consent or are unwilling to comply with study requirements to provide medical data for further analysis and research.